THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2025-01258
- Event Type
- Death
- Date Received
- March 5, 2025
- Date of Event
- February 10, 2025
- Report Date
- May 29, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED PUMP STOP EVENTS ASSOCIATED WITH THE DISCONNECTION OF THE DRIVELINE, WHICH APPEARED CONSISTENT WITH THE REPORT OF ATTEMPTED SYSTEM CONTROLLER EXCHANGES. A SPECIFIC CAUSE FOR THE PATIENT¿S INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, ANALYSIS OF THE SUBMITTED LOG FILES ALSO CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILES COLLECTIVELY CONTAINED EVENTS FROM (B)(6) 2025 THROUGH (B)(6) 2025. THE DRIVELINE WAS DISCONNECTED TWICE ON (B)(6) 2025, CAUSING THE PUMP TO STOP. FOLLOWING EACH RECONNECTION OF THE DRIVELINE THE PUMP RESUMED OPERATION AT THE SET SPEED WITHOUT ISSUE. THE DRIVELINE WAS DISCONNECTED AGAIN ON (B)(6) 2025, CAUSING THE PUMP TO STOP AND THE DRIVELINE REMAINED DISCONNECTED FOR THE REMAINDER OF THE FILE. THESE EVENTS APPEARED CONSISTENT WITH THE REPORT OF ATTEMPTED SYSTEM CONTROLLER EXCHANGES PERFORMED BY THE PATIENT AND WIFE. LOW FLOW HAZARD ALARMS WERE CAPTURED ON (B)(6) 2025. NO OTHER NOTABLE EVENTS OR ALARMS ASSOCIATED WITH THE PUMP WERE CAPTURED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, DOCUMENT AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, BLEEDING, INFECTION AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 ALSO ADDRESSES ALL PUMP PARAMETERS. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS AND EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS", AND SECTION 2 OF THE PATIENT HANDBOOK, "HOW YOUR HEART PUMP WORKS", WARN THAT IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. THESE SECTIONS FURTHER INSTRUCT THAT IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, IT SHOULD BE PROMPTLY RECONNECTED TO RESUME PUMP OPERATION. THE PATIENT HANDBOOK FURTHER EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. SECTION 2 OF THE IFU ALSO CONTAINS A SECTION TITLED "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", WHICH PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED ON 28MAR2025 THAT THE PATIENT PASSED AWAY ON (B)(6) 2025 DUE TO WITHDRAWAL OF SUPPORT IN PALLIATIVE CARE. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND DEVICE PARAMETERS WERE WITHIN NORMAL LIMITS. THE PUMP WAS NOT EXPLANTED, AND AN AUTOPSY WAS NOT PERFORMED.
IT WAS REPORTED THAT THE PATIENT HAD SOME ISSUES OVER THE PAST SEVERAL MONTHS WITH INCREASING DIURETIC REQUIREMENTS DUE PRESUMED RIGHT HEART FAILURE. IT WAS NOTED THAT THE PATIENT HAD COVID PNEUMONIA ON (B)(6) 2024. ON (B)(6) 2025 RAMP STUDY WAS DONE. THE PATIENT WAS GIVEN IV FUROSEMIDE 100MG IN CLINIC ON (B)(6) 2025 AS A RESULT OF THE CATHETERIZATION WITH PLANS TO SEE AGAIN IN THE UPCOMING WEEK. LATE ON (B)(6) 2025, THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) STARTED ALARMING WHILE SITTING ON A CHAIR. THE PATIENT CHANGED THEIR BATTERIES, BUT THE ALARM CONTINUED. THE PATIENT WAS THEN TO CHANGE THE SYSTEM CONTROLLER. THEIR SPOUSE THOUGHT THE PATIENT SHOULD CALL FOR HELP, BUT THE PATIENT SAID THEY HAD THINGS UNDER CONTROL. IN FRUSTRATION, THE SPOUSE WENT TO THE KITCHEN TO MAKE DINNER AND WHEN COMING BACK, THE PATIENT WAS UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WERE CALLED WHO CAME AND STARTED CARDIOPULMONARY NECESSITATION. IN THE MEANTIME, THE SPOUSE DESPERATELY TRIED TO CHANGE THE CONTROLLER AND WAS EVENTUALLY ABLE TO GET THE PATIENT ON THE NEW CONTROLLER. THE PATIENT WAS AWAKENED AT SOME POINT ALONG THE WAT. IT WAS UNKNOWN HOW LONG THE PATIENT WAS DISCONNECTED BUT IT APPEARED TO BE 3 ATTEMPTS. IN THE EMERGENCY ROOM (ER) THE PATIENT WAS RESPONSIVE, AND THE DEVICE WAS WORKING. THE PATIENT WAS INTUBATED TO PROTECT THEIR AIRWAY AS THEY COUGHED UP BLOOD. A USUAL BLOODWORK WAS DONE WHICH WAS NOT CONCERNING EITHER THAN THE INTERNATIONAL NORMALIZED RATIO (INR). LACTATE 3.3, CREATININE WAS 172 (CLOSE TO THE PATIENT'S USUAL), AND HEMOGLOBIN WAS UNCHANGED FROM PREVIOUS. COMPUTED TOMOGRAPHY WAS DONE WHICH BASICALLY SHOWED SOME INFILTRATES IN RIGHT LUNG AND SOME BLOOD. THE PATIENT DID RECEIVE 2 LITERS OF FLUID FROM THE ER AND WAS PLACED ON BROAD SPECTRUM ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED ON 24FEB2025 CONFIRMED THAT THE PATIENT WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS DUE TO PNEUMONIA. NO ARRYTHMIAS. IN THE INTENSIVE CARE UNIT (ICU), INITIAL ASSESSMENT SHOWED A LOW PULSATILITY INDEX (PI), MEAN ARTERIAL PRESSURE (MAP) WAS 65. THERE WAS NO EVIDENCE FOR BLOOD LOSS OR DISTRIBUTE SHOCK. THE PATIENT WAS NOT DEHYDRATED, AND THEIR CENTRAL VENOUS PRESSURE (CVP) WAS APPROXIMATELY 16 AND THEIR CARDIOMEMS WAS ASSESSED: PA 47/ 24 AT 4800 RPM. THESE VALUES WERE NOT MUCH DIFFERENT THAN THE ASSESSMENT FROM A WEEK AGO. DESPITE THE HEMODYNAMICS, RIGHT VENTRICULAR FAILURE WAS SUSPECTED. IN THE EVENING, THE RPM WAS DOWN FROM 4800 TO 4600. IT WAS NOTED THAT THERE WAS REALLY NO DATA FROM THE DEVICE AS IT WAS BRAND NEW. OVERNIGHT THE DEVICE STARTED TO ALARM AGAIN AT AROUND 0300. THE PATIENT WAS GIVEN SOME MORE FLUID AS THE PI REMAINED LOW. IN ADDITION, NOREPINEPHRINE WAS STARTED TO ATTAIN MAP OF 70 AND SUBSEQUENTLY 75. THIS WOULD HELP FOR A WHILE AND THEN THE ALARMS WOULD GO OFF. THE PATIENT WAS THEN STARTED WITH DOBUTAMINE, AND DIURESIS WAS DOWN TO CVP 12. NOREPINEPHRINE WAS WEANED. THE ALARMS ALSO STOPPED. THE HEARTMATE TOUCH WAS REVIEWED, AND IT LOOKED LIKE MULTIPLE SPIN DOWNS. THE DOBUTAMINE WAS BUMPED TO 5UG. GRADUALLY THE PI CAME UP TO 4-6 AND FLOWS INCREASED. DESPITE THE CARDIOMEMS, THE FINDINGS WERE THOUGHT TO SUPPORT RV FAILURE. THE PATIENT WAS IN STABLE CONDITION. THEY WERE COOLED AND WAS BEING WARMED UP ON (B)(6) 2025 REQUIRING MORE DIURESIS AND WAS TO BE SWITCHED TO MILRINONE. MOST OF THE EVENTS WERE COMMUNICATED BY THE SPOUSE AND WHEN THE ORIGINAL CONTROLLER THE SPOUSE PRESENTED WAS INTERROGATED, NOTHING MUCH WAS SEEN EXCEPT FOR THE POWER DISCONNECTIONS. THE EVENT LOG FILE FROM THE ORIGINAL PRIMARY CONTROLLER THAT WAS EXCHANGED CAPTURED SOME LOW VOLTAGE ADVISORY EVENTS ON (B)(6) 2025 AT 18:58-18:59 WHILE USING BATTERY POWER. THE PATIENT APPEARED TO HAVE ATTEMPTED TO EXCHANGE THE BATTERIES BUT ATTACHED A BATTERY THAT WAS ALREADY IN LOW VOLTAGE STATE RESULTING IN CONTINUED LOW VOLTAGE ADVISORY EVENTS. THE CONTROLLER WAS EXCHANGED SHORTLY AFTER AT 19:04 AND THEN THE ORIGINAL RECONNECTED AGAIN AT 19:09 THEN WAS DISCONNECTED ONCE AGAIN AT 19:18.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375012 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 6540873 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death| R| H |